This application claims priority from Italian Patent Application Number IT MI 99A001784, filed Aug. 6, 1999.
The present invention provides an apparatus and process which can stimulate a state of complete continence of the neosphincter in the preparation of continent neostomies. More specifically, the present invention provides an apparatus and process for the stimulation of a state of complete continence of the neosphincter in the preparation of continent neostomies, comprising an electrocatheter with an electrode inserted above the neostomy near, and in electrical contact with, transplanted muscle tissue (i.e., a strip of antral gastric musculature) which has been transplanted to the distal segment of the intestine or other organ where an ostomy has been created. The apparatus and process can restore the organic continence in a subject who has undergone therapeutic alteration of an indispensable segment of the visceral anatomy (i.e., the anus or the urinary bladder), thereby significantly improving quality of life.
The first abdominal-perineal resection for rectal neoplasm was performed by Miles in 1908. Such treatments, although justified in light of the radical nature of the underlying disease (e.g., cancer), involved extensive destruction, including the loss of the sphincter, and were generally accepted by the patient only with great reluctance. Following perineal abdominal amputation for neoplastic intestinal disease near the anus, the principal problem remains that of restoring the patient""s fecal continence. In an attempt to solve this problem, surgical research has been aimed at two principal goals:
(1) reduction of the indications, even considering the serious nature of the cancer, by performing low or ultra-low resections with the help of the preparation and development of mechanical suturing technology; and
(2) reconstruction of a pseudo-continent anus, possibly in the original anatomical site.
This second, and more ambitious, goal or objective (i.e., the preparation or reconstruction of a neosphincter) has been divided in recent years into two major research trends. Pickrell et al. (xe2x80x9cConstruction of Rectal Sphincter and Restoration of Anal Incontinence by Transplanting Gracile Muscle: Report of 4 Cases in Children,xe2x80x9d Ann. Surg. 135-853 (1952)) used strips of striated muscle, gracilis muscle, or more recently the major adductor for the attempted reconstruction. Shmidt (xe2x80x9cThe Continent Colostomy,xe2x80x9d World J. Surgery, 805-808 (1982)) used strips of smooth intestinal muscle.
Beyond the problems of technical implementation, there is the substantial difference in the physiological properties of the two biological materials used. The striated muscle cannot guarantee a durable contraction when needed; for this reason, additional methods of electrostimulation and biofeedback have been used to improve its resistance. Smooth muscle, on the other hand, can offer a tonic contraction for long periods of time, making it more similar to the function of the natural sphincter. In addition, even when it is denervated and devascularized, smooth muscle will not atrophy. On the contrary, it has a distinct and early tendency to create secondary revascularization, with the possibility of reinnervation as well.
This smooth muscle behavior permits a rapid resumption of its contractile activity with the appearance of a persistent and durable tonus, replaced by relaxation under the effect of substantial pressure from above. The use of smooth muscle to create a neosphincter according to Shmidt (1982) appears to be the most promising method. Indeed, the clinical results obtained are generally satisfactory in that it reasonably appears that pseudo-continence has been achieved. However, this technique does not allow for a state of complete continence, which is the optimal condition for the patient.
Thus, there remains a need for improved apparatus and procedure for stimulating or providing a state of complete continence of the neosphincter in the preparation of continent neostomies. The present invention provides such apparatus and procedure.
The present invention provides an apparatus and process which can stimulate a state of complete continence of the neosphincter in the preparation of continent neostomies. More specifically, the present invention provides an apparatus and process for the stimulation of a state of complete continence of the neosphincter in the preparation of continent neostomies, comprising transplanting muscle tissue consisting of a strip of antral gastric musculature onto the distal segment of the intestine or other organ where an neostomy has been created and implanting an electrocatheter with an electrode inserted above the neostomy near the transplanted muscle. The apparatus can completely restore the organic continence in a subject who has undergone therapeutic alteration of an indispensable segment of the visceral anatomy (i.e., the anus or the urinary bladder), thereby significantly improving quality of life.
The present invention provides a process for achieving a state of complete continence in a patient in need of a neostomy for attachment of an endoabdominal organ via an endoabdominal lumen to a neostomy site, said process comprising transplanting a strip of antral gastric musculature to the distal segment of the endoabdominal lumen adjacent to the neostomy site and implanting an electrocatheter with at least one electrode in electrical contact with the strip of antral gastric musculature, whereby stimulation of the strip of antral gastric musculature through the electrode allows generation of a reverse pressure gradient inside endoabdominal lumen and provides the state of complete continence.
The present invention also provides an apparatus for achieving a state of complete continence in a patient in need of a neostomy for attachment of an endoabdominal organ via an endoabdominal lumen to a neostomy site, said apparatus comprising an implantable electrocatheter with at least one electrode in electrical contact with a strip of antral gastric musculature transplanted to the distal segment of the endoabdominal lumen adjacent to the neostomy site, whereby stimulation of the strip of antral gastric musculature through the electrode allows generation of a reverse pressure gradient inside endoabdominal lumen and provides the state of complete continence.
The present apparatus and process use a strip of smooth muscle which is transplanted to the endoabdominal lumen attached to the neostomy. Preferably, the strip of smooth muscle is taken from about 10 cm of the small intestine which, after being prepared on the bench (i.e., ex vivo surgery), is transplanted back into the patient (i.e., autotransplanation). As compared to the known use of intestinal smooth muscle strips (i.e., the Shmidt technique), the present invention preferably involves the autotransplant of gastric antral muscle onto the distal segment of the intestine or any other organ where an ostomy has been created. Using electrostimulation from an electrocatheter with an electrode inserted above the neostomy near the transplanted muscle tissue (i.e., the transplanted strip of antral gastric musculature), the present invention allows restoration of organic continence in a subject who has undergone surgical alteration of an indispensable visceral anatomical segment, such as the anus or the urinary bladder. Thus, this invention provides an apparatus and a procedure which are suitable for the preparation of continent neostomies and are capable of guaranteeing an essentially complete state of continence.